Use of Baska mask versus Ambu-aura gain in adult patients undergoing elective surgery under general anaesthesia : A comparative study.

Not yet recruiting

Conditions: Malignant neoplasm of breast of unspecified site,

Registration Number: CTRI/2022/07/044255

Lead Sponsor: Dr Shalini A

Brief Summary: Supraglottic airway (SGA) devices are used toventilate the patients by delivering gases above the level of vocal cords. Based on their differentsealing mechanisms and aspiration protection designs, SGA devices are broadlyclassified into the first generation devices (inflatable cuff), secondgeneration (preshaped) and third generation devices (self energizing) as perMillerâ€™s new classification.

Ambu aura gain is asecond generation SGA made of polyvinyl chloride meant for single use withpreformed shape. It is the only anatomically curved SGA device with integratedgastric access and also provides high sealing pressures that reduce the risk ofaspiration leading to higher safety level. It has bite block andalso a wider airway tube providing as an intubation conduit similar to Ambuaura once and LMA proseal. Baska mask is a novelthird generation SGA made of medical grade silicone and available in four sizesof 3, 4, 5 and 6 based on body weight. The characteristic feature of this mask is thatthe airway pressure is transmitted intermittently to the flexile element of thecuff so that it inflates and deflates with each positive pressure inspirationand expiration respectively thus forming a perfect seal, reducing leaks andmaking intermittent positive pressure ventilation very efficient.

Many studies areavailable comparing the efficiency of 3rd generation Baska mask withvarious second generation SGA devices by various authors. Currently, there are no available studies that have compared the efficiency ofAmbu aura gain and Baska mask. Hence this prospective randomized comparativestudy is being undertaken to compare the efficacy and safety between Ambuaura gain and Baska mask as supraglottic airway device in adult patientsundergoing elective surgery under general anaesthesia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Age group 18 â€“ 60 years 2.ASA I and II 3.Patient who give valid informed written consent 4.Mallampati class 1 and 2 5.Patient undergoing elective surgeries under general anaesthesia with controlled ventilation 6.Duration of surgery <2 hours.

Exclusion Criteria

1.Age <18years and > 60 years 2.ASA grade III and above 3.Mallampati class 3 and above 4.Patients with systemic cardiovascular, respiratory, hepatic, renal or neurologic disorders 5.Emergency surgeries 6.Patients with decreased mouth opening 7.Patients with increased risk of aspiration 8.Patients with BMI > 30kg/m2 9.Patients with abnormal or distorted anatomy of oropharynx.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Oropharyngeal seal pressure	1. Oropharyngeal seal pressure \| 2. Ease of placement of device \| 3. Position of the ventilating orifice in relation to the larynx using fibreoptic bronchoscope. \| 4.Ease of removal of device
2. Ease of placement of device	1. Oropharyngeal seal pressure \| 2. Ease of placement of device \| 3. Position of the ventilating orifice in relation to the larynx using fibreoptic bronchoscope. \| 4.Ease of removal of device
4.Ease of removal of device	1. Oropharyngeal seal pressure \| 2. Ease of placement of device \| 3. Position of the ventilating orifice in relation to the larynx using fibreoptic bronchoscope. \| 4.Ease of removal of device
3. Position of the ventilating orifice in relation to the larynx using fibreoptic bronchoscope.	1. Oropharyngeal seal pressure \| 2. Ease of placement of device \| 3. Position of the ventilating orifice in relation to the larynx using fibreoptic bronchoscope. \| 4.Ease of removal of device

Secondary Outcome Measures

Name	Time	Method
1.Hemodynamic response, SpO2, EtCO2	2.Incidence of postoperative complications graded as mild, moderate and severe.

Trial Locations

Locations (1): K R Hospital, MMC&RI
🇮🇳
Mysore, KARNATAKA, India
K R Hospital, MMC&RI
🇮🇳Mysore, KARNATAKA, India
Dr Shalini A
Principal investigator
9986061614
shalinianand20@gmail.com